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Gifts For Industry: From Waived Inspections To Pre-Market Leeway, US FDA Woos Firms For Maturity Pilot

FDA wants to give away a basket of goodies to manufacturers that voluntarily play in an upcoming pilot program that will help the agency determine the manufacturing maturity of device-makers by using the CMMI maturity model appraisal process. Incentives to join the pilot include FDA delaying regularly scheduled facility audits, waiving preapproval inspections, allowing more leeway for 30-day notices and pre-market submissions, and easing up on the issuance of FDA warning letters. A major goal of the initiative is for the agency to have greater confidence in firms that demonstrate high-quality, gold-star quality systems so it can focus its limited resources on less mature, troublesome firms.

Quality Control Compliance FDA

India’s Simmering Device-Pricing Controversy – Many Hues

An uneasy calm prevails in the medical devices sector in India following regulatory action to cap stent prices and, more recently, a price data-gathering initiative for certain other products. Is this just the lull before another, more turbulent storm that lies ahead for industry?

India Pricing Strategies Market Access

Medtronic Hits Targets In 'Solid' Fiscal 2017

Medtronic, medtech's No. 1 player, did not disappoint the market with its final fiscal quarter performance. With revenue and profit figures exceeding analysts' expectations, the group's outlook for fiscal 2018 is also looking equally positive.

Sales & Earnings Companies Commercial

Device Week – May 26, 2017

On this week's Medtech Insight podcast: US FDA Commissioner Scott Gottlieb defends his agency’s budget; AdvaMed’s new chair talks to Medtech Insight about challenges he faces and where he’s leading the industry group; a close look at mobile technology company Qualcomm Life; a two-part Medtech Insight series on pain management is highlighted.

FDA Leadership Legislation
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Policy & Regulation Explore this Topic

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Malaysian Regulator Seeks Feedback On Conformity Assessment Expectations

Malaysia’s Medical Device Authority has issued a draft guideline for comment on conformity assessment and what manufacturers must do to demonstrate that their product is safe and performs as intended.

Malaysia Compliance Policy & Regulation

US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones

President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude defibrillators and Bayer HealthCare's Essure birth control coils, will cause harm rather than be recalled, Rep. Rosa DeLauro said at a May 25 House Ag/FDA subpanel hearing. FDA Commissioner Scott Gottlieb told DeLauro the agency needs to supply "the right tools" to firms during device development so similarly flawed devices aren't put on the market, and he noted that the lifting of a hiring freeze at the agency earlier in the day would free the agency to work harder on such issues.

Policy & Regulation Legislation United States

IVD UK Spring Meeting: The Costly But Necessary Route To IVDR Compliance

Second of two articles covering discussion at the spring 2017 meeting of the British In Vitro Diagnostics Association: Not all will survive unscathed as the EU IVD Regulation becomes an operational reality.

In Vitro Diagnostics Europe

European Commission Makes Final Decision On Cranberry Products

Several manufacturers in the EU have marketed cranberry capsules as medical devices to gain regulatory and marketing advantages. Others have lobbied against this "unfair practice." France took the matter to the European Commission, which took action – the first time the commission employed its "borderline"-product designation authority.

Medical Device Europe

Trump Budget: 71% Of US FDA Device Funding Would Come From User Fees

The Trump White House is not backing down in its push to renegotiate the US FDA user-fee reauthorization deals that were inked during the Obama administration. The FY 2018 budget request would ask for more than a $200m increase in fees from device companies in the coming fiscal year to counterbalance major cuts in appropriations from Congress. That would make the agency's device program dependent on user fees for about 71% of its budget, versus about 27% currently. But Congress has already said it opposes the plan.

Legislation United States

Warning Letter Roundup & Recap – May 23, 2017

US FDA did not release any device-related warning letters the week of May 23.

Medical Device Device Warning Letters

Podcast: Nadim Yared Hits The Ground Running As AdvaMed Chair

In a podcast interview to discuss his initial experience as chairman of AdvaMed, CVRx CEO Nadim Yared talks about the group's laser focus on device-tax repeal, irrespective of broader GOP health-care debates and controversy, its capacity to handle unpredictability and change in Washington, DC, and more.

Leadership Legislation

Abbott Catheter Recall Designated As Class I

A tight balloon sheath in some Abbott coronary catheters has been linked to adverse events including air embolism, thrombosis, heart attack and death. Almost 450,000 units are being recalled worldwide.

Recalls Safety

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Q1 Recalls Snapshot: Recalled Device Units Drop To Lowest Level Since 2013; Recall Events Dip Slightly

There were 284 recall events from January through March, down 9% from Q4 2016's 313 corrections and removals. Check out our Q1 recalls infographic.

Recalls Quality Control

More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Legislation Policy

Singapore Consults On Implementing New Device Distribution Standard

Singapore’s Health Sciences Authority is inviting feedback on a draft guideline to help medical device importers and wholesalers comply with its new standard on good distribution practice. The earlier technical specification on this topic will be phased out by 2020.

Regulation Quality Control

Commercial Explore this Topic

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Qualcomm: A New Kind Of Medical Device Company

The mobile-technology company is trying to corner the wireless needs of the health-care industry, and is pushing for adoption of value-based health-care models that would be dependent on more data-sharing to justify costs based on patient outcomes.

Business Strategies Clinical Trials Commercial

Latest From Commercial

MIXiii Biomed 2017: Aging, Technology & Robotics In The Digital World

How can medical technology improve the lives of our rapidly aging population? Companies from across the Israeli medtech industry, as well as delegates from around the globe, convened at the 16th MIXiii Biomed life sciences and technology meeting in Tel Aviv to discuss the impact of aging and demonstrate the latest innovations in the field.

StartUps and SMEs Innovation

IVD UK Spring Meeting: Diagnostics Get New Market Access Tools – But At A Price

First of two articles covering discussion at the spring 2017 meeting of the British In Vitro Diagnostics Association: The UK IVD companies are soon to get new tools designed to make market access for innovations easier and more predictable. This is welcome news, given the backdrop of Brexit and the costly route to compliance to the new EU IVD Regulation compliance.

United Kingdom Commercial

Pain Management II: Competition Intensifies For Spinal Cord Stim Market's Big Three

In the global pain management market, spinal cord stimulation (SCS) systems are expected to continue to be the fastest-growing segment with increasing competition among device manufacturers to develop innovative, targeted therapies. In this second article of a two-part series, we'll discuss the competitive landscape in the SCS market, the key players, emerging companies and their respective technologies.

Neurology Market Intelligence

Pain Management I: Spinal-Cord Stim To Grab Ever-Bigger Market Share

The field of neuromodulation for treating chronic pain is growing rapidly, especially in the fastest-growing spinal cord stimulation (SCS) market segment, which is expected to hit $2.4bn by 2021. This article, the first of a two-part series, will explore what the key drivers and limitations are for the SCS market and provide insight from three established pain management specialists on what factors will push wider adoption of this therapy.

Neurology Market Intelligence

New Acquisition And Positive Data Inflates Philips' Respiratory Biz

Philips has expanded its sleep and respiratory care unit with the acquisition of US firm Respiratory Technologies, Inc., which offers a noninvasive airway clearance solution for patients with chronic respiratory problems. Separately, as an additional boost to this business, a clinical study sponsored by the Dutch multinational gave further support for the combined used of home noninvasive ventilation with oxygen therapy to delay hospital readmissions in COPD patients.

Respiratory M & A

Device Week – May 19, 2017

On this week's Medtech Insight podcast: ex-US FDA Commissioner Bob Califf talks new commish and Trump; the latest on the Food and Drug Administration Reauthorization Act (FDARA); FDA recommends approval for the TransMedics Organ Care System; blood lead tests made by Magellan Diagnostics may give bad results; updates from the Heart Rhythm Society Scientific Sessions in Chicago and EuroPCR 2017 in France.

FDA Medical Device

Clinical R&D Explore this Topic

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Device Debuts: Spinal Innovation From NuVasive, Life Spine; Teleflex Targets EuroPCR For Arrow AC3 Optimus; Abiomed Pushes 3-G Impella

This edition of Device Debuts covers the innovative devices introduced into commercial markets since the mid-April, typically a busy time for product launches as it coincides with spring's big medical meetings. This includes a series of spine-surgery technologies showcased at the AANS meeting and devices that support blood circulation during interventions that were featured at EuroPCR and SCAI.

Orthopedics Cardiology Innovation

Latest From Research & Development

Blue Earth Extends Global PET Reach With EU Approval

Blue Earth Diagnostics, a molecular imaging agent specialist spun out of GE Healthcare, has secured EU approval to market its PET tracer for detecting recurrent prostate cancer. Axumin, which was approved in the US a year ago, is said to be only PET imaging agent for this indication in the EU.

Diagnostic Imaging Cancer

Starts & Stops: New Trial Starts Led By Peripheral Vascular Interventions

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions the past month or so. Over the last month, 38 new trials started, 17 trial were completed, one trial was "reinitiated," and four trials were terminated or suspended, according to Meddevicetracker.

Clinical Trials Starts & Stops

New Acquisition And Positive Data Inflates Philips' Respiratory Biz

Philips has expanded its sleep and respiratory care unit with the acquisition of US firm Respiratory Technologies, Inc., which offers a noninvasive airway clearance solution for patients with chronic respiratory problems. Separately, as an additional boost to this business, a clinical study sponsored by the Dutch multinational gave further support for the combined used of home noninvasive ventilation with oxygen therapy to delay hospital readmissions in COPD patients.

Respiratory M & A

EuroPCR 2017: TAVR Continues To Beat Surgery; Bioabsorbable Stents Not Going Away

The EuroPCR conference in Paris is the most important annual interventional cardiology conference in Europe and this year's edition brought more data from clinical trials of both established catheter-based technologies and innovative new devices.

Cardiology Clinical Trials

INS 2017 Aims To Offer Sneak Peek Into Future Neuromodulation Trends

As scientific and industry experts prepare to gather in Edinburgh, Scotland, later this month for the 13th International Neuromodulation Society Congress, Medtech Insight spoke to Timothy Deer, INS president and a pain-management specialist, about what's ahead in neuromodulation and what to expect at the meeting.

Research & Development Innovation

HRS 2017: EBR's Leadless CRT Feasibility; Watchman Registry Data; A Novel AF Ablation Catheter From BW; And More Medtronic CRT Data

Results from "real-world" registries of established devices, along with encouraging early results from novel devices were among the highlights of Heart Rhythm 2017, the annual scientific sessions of the Heart Rhythm Society, held in Chicago May 10-13.

Cardiology Clinical Trials
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